Glenmark Pharmaceuticals Inc., USA 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-D-0098-2025
Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx… Recall
Issued December 11, 2024 · Glenmark Pharmaceuticals Inc., USA
In December 2024, Glenmark Pharmaceuticals Inc., USA recalled the Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
What you should do
- 1 Stop using Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Glenmark Pharmaceuticals Inc., USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Glenmark Pharmaceuticals Inc., USA
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0098-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Glenmark Pharmaceuticals Inc., USA has 53 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.